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Clinical Trial Summary

The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: - Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. - Undergo physical exams, vital signs assessments, ECGs, and blood draws - Complete assessments of pain, sleep, functional status, and perception of change


Clinical Trial Description

EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Three Phase 1 studies of EC5026 have been conducted in healthy volunteers; a Phase 1a Single Ascending Dose (SAD) study, a Phase 1a Fed-Fasted study, and a Phase 1b Multiple Ascending Dose (MAD) study. The Phase 1b MAD study evaluated the safety, tolerability, and PK of 2 sequential ascending dose regimens of oral EC5026, administered once daily for 7 consecutive days, in healthy volunteers. The present study will evaluate the safety and tolerability, as well as target engagement and pharmacodynamics, of EC5026 administered as multiple doses in subjects with neuropathic pain due to spinal cord injury. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06438471
Study type Interventional
Source EicOsis Human Health Inc.
Contact Laura Carbone, MD, MS, FACP
Phone 706-721-6909
Email LCARBONE@augusta.edu
Status Recruiting
Phase Phase 1
Start date July 2024
Completion date July 2025

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